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Compliance With Once-Daily Divalproex Extended-Release Tablets (Depakote-ER) Versus Multiple-Daily Dose Valproic Acid Capsules (Depakene) in Epilepsy:

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ClinicalTrials.gov Identifier: NCT00356018
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : June 1, 2012
Information provided by:
Orlando Health, Inc.

Brief Summary:
To determine, in a randomized, parallel open-label fashion, compliance rates between once-daily extended-release divalproex sodium tablets (Depakote-ER®, Abbott Labs) versus multiple-daily dose valproic acid capsules (Depakene®, Abbott Labs) in an epilepsy population.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: Compliance Phase 4

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 5 participants
Time Perspective: Prospective
Official Title: Compliance With Once-Daily Divalproex Extended-Release Tablets (Depakote-ER) Versus Multiple-Daily Dose Valproic Acid Capsules (Depakene) in Epilepsy: A Randomized, Parallel, Prospectively-Controlled Outpatient Comparison
Study Start Date : July 2006
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The population includes both patients whose seizures are relatively well controlled on their present conventional, enteric-coated twice-daily or three-times daily Divalproex sodium regimen.

Inclusion Criteria:1) Patients, age 16 and above, currently taking Divalproex-DR for any seizure disorder; 2) Other AEDs are permitted concurrently, although compliance with these will not be recorded. Other medications for co-morbid disease are permitted, provided no plans for changes in medications used for the treatment of the concomitant disorder are expected.

3) Patients must demonstrate a 75% or greater compliance rate with DR via calendar during the week of familiarity with the MEMs unit. The threshold value of 75% has been chosen since research shows that people take approximately 75% of their AED(s) as prescribed (13,14), and the same numerical value is frequently used in determining whether or not to retain a patient in clinical Phase 2a-3b industry-sponsored study.

Exclusion Criteria:1) patients with a recent history of status epilepticus; 2) patients who have refractory or unstable epilepsy; 3) patients with acute illnesses requiring changes in concurrent drugs; 4) patients unwilling to change from their present DR regimen to divalproex-ER or IR-VPA.

5) Patients unwilling or unable to utilize the MEMs monitoring unit; 6) Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356018

United States, Florida
Orlando Regional Lucerne Hospital
Orlando, Florida, United States, 32801
Sponsors and Collaborators
Orlando Health, Inc.
Principal Investigator: Jane Boggs, MD Physician

ClinicalTrials.gov Identifier: NCT00356018     History of Changes
Other Study ID Numbers: 3D20-2006
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012

Keywords provided by Orlando Health, Inc.:

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs